Compounding Pharmacies File Suit over “Unlawful” Insurance Claim Denials

Compounding Pharmacies File Suit over “Unlawful” Insurance Claim Denials

Companies claim that the blanket denial of coverage of compounding ingredients is against federal law. It could also affect access to critical natural health products. Action Alert! In August we told you about pharmacy benefit managers (PBMs)—companies that process prescriptions for insurance companies and corporations, and use their size to negotiate low prices with drug makers and pharmacies. They […]

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How a Tooth-Whitening Lawsuit Landed before the Supreme Court

How a Tooth-Whitening Lawsuit Landed before the Supreme Court

—and why their decision will have far-reaching ramifications for state licensing boards. Last year we told you about the Federal Trade Commission’s investigation of the North Carolina dental board. The FTC decided the board had attempted to monopolize the teeth whitening business, and found it had illegally thwarted competition through cease-and-desist letters. The board—composed mainly of private dentists—had […]

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Problems with Compounding Regulation?

Problems with Compounding Regulation?

Recent regulations released by the FDA contain several provisions that are harmful to doctors, patients, and compounding pharmacists. Office Use: This is an area of the rulemaking that has garnered the biggest reaction from the compounding community. Congress and the FDA have required a patient-specific prescription for all drugs compounded, with a narrow exception if […]

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How is Compounding Regulated?

How is Compounding Regulated?

Compounding has recently undergone a regulatory overhaul by Congress and the FDA. In November 2013, the Drug Quality and Security Act (DQSA) was signed in to law, amending the federal Food, Drug, and Cosmetic Act (FDCA) and overhauling the regulation of compounding. In July 2014, the FDA released rules and guidances and other documents implementing […]

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